K-number	K121597
Device name	ESON NASAL MASK
Applicant	Fisher & Paykel Healthcare Limited
Product code	BZD
Device class	Class II
Decision date	Oct 2, 2012
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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ESON NASAL MASK

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